Evaluating the Safety and Efficacy of Oral E7080 in Medullary and Iodine-131 Refractory, Unresectable Differentiated Thyroid Cancers, Stratified by Histology
The purpose of this study is to determine the safety and efficacy of oral E7080 in medullary and iodine-131 refractory, unresectable differentiated thyroid cancers.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II, Multicenter, Open-label, Single Arm Trial to Evaluate the Safety and Efficacy of Oral E7080 in Medullary and Iodine-131 Refractory, Unresectable Differentiated Thyroid Cancers, Stratified by Histology|
- Determine the effect of E7080 on the objective tumor response rate according to Response Evaluation Criteria in Solid Tumors (RECIST). [ Time Frame: Months 2, 4, 6, 8 and every two months thereafter. ] [ Designated as safety issue: No ]
- Adverse events, laboratory assessments, and electrocardiograms (ECGs). [ Time Frame: AEs reported during all cycles; labs at each week in Cycle 1 and Day 1 at other cycles; ECGs at Day 1 of each cycle ] [ Designated as safety issue: Yes ]
- Progression-free survival, duration of response, and time to response. [ Time Frame: At 12 weeks and 6 months ] [ Designated as safety issue: No ]
- Overall Survival. [ Time Frame: At 6 and 12 months, every 3 months in 1st 2 years off study, every 6 months in Years 3 & 4, and yearly thereafter ] [ Designated as safety issue: No ]
- Pharmacokinetic profile. [ Time Frame: Days 1 and 8 of Cycle 1 and Day 1 of other cycles ] [ Designated as safety issue: No ]
|Study Start Date:||August 2009|
|Estimated Study Completion Date:||October 2013|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
E7080 given orally continuously at 24 mg, once a day.
This will be an open-label study at approximately 50 study centers in the US, Europe and other countries. The study will consist of a screening period (Pre-Treatment Phase), 28-day treatment cycles (Treatment Phase), and a study termination/final visit and survival follow-up. Patients showing clinical benefit will continue to receive the study drug (Extension Phase) and will be followed up with the appropriate assessments.
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